| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00105-1 |
| Product Name/Description |
Allura Systems: Field extensions Vascular R7.6
Product Code: 722134
Applies to: Actuator Long Assy: 989600-184-654
ARTG number: 98560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips has received customer feedback where the Monitor Ceiling Suspension (MCS) system fell to its lowest position. In this specific occasion it collided with the table top. The investigation initiated concluded that the cause of the failure was an assembly error of the Actuator of the MCS. When the Monitor Ceiling Suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room or with other equipment in close proximity of the MCS. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will replace all MCS actuators on affected devices. Until this action can be undertaken straps being fitted around the MCS to prevent the monitors from falling down in the event that the actuator fails.
In order to avoid any risk for patients, users or bystanders are recommended the following until the containment action has been implemented:
- Do not position or move the Monitor Ceiling Suspension above the patient.
- Do not allow staff to stand under or close to the Monitor Ceiling Suspension.
Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 03/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |